Kornimate/medical-research-clean huggingface dataset:
nerve decompression for ulcer recurrence avoidance (dura)

Conditions: Diabetic Ulcer of Plantar Aspect of Left Foot; Diabetic Ulcer of Plantar Aspect of Right Foot; Diabetic Polyneuropathy

Summary: anecdotal reports and scientific literature suggest that the risk of recurrence of diabetic foot ulcers can be minimized by nerve decompression procedures at anatomic sites of nerve pinching and entrapment. historical risk of 25% annually has been reported to decrease by \>80% to under 5% yearly. since an open wound precedes the large majority (85%) of amputations in diabetes, avoidance of ulcer recurrences is important. this study tests the current academic opinion that nerve decompression will not decrease ulcer recurrence risk. null hypothesis: nerve decompression will not decrease diabetic foot ulcer recurrence risk.

diabetes patients with a recently healed, non-ischemic plantar diabetic foot ulcer will be randomized to "best care" standard post-ulcer treatment or to best care plus bilateral nerve decompression by external neurolysis at 4 fibro-osseous tunnel sites in the leg and foot. comparison of the control group with standard care to the surgical intervention group will be made for subsequent appearance of a plantar foot ulcer and ulcer recurrence risks will be calculated. additional subjective and objective secondary outcomes will be monitored. null hypothesis: nerve decompression will not decrease diabetic foot ulcer recurrence risk. if protection against ulcer occurrence were to be confirmed, a change in the treatment paradigm for diabetic neuropathy and foot ulcer could be appropriate.

Eligibility criteria:
inclusion criteria: * type 1 or type 2 diabetes mellitus * diabetic sensorimotor peripheral neuropathy * recently healed plantar neuropathic diabetic foot ulcer (\< 18 months) * at least one palpable foot or ankle pulse or abi\>0.8 bilaterally. * recent hgb a1c \< 9.0% * ankle edema absent or mild exclusion criteria: * ischemic peripheral vascular disease or ankle-brachial index (abi)\<0.8 * history of peripheral vascular arterial surgery * history of peripheral nerve or lumbar disc surgery * alcohol abuse(more than 2 drinks/day) * untreated thyroid disorders * b12 or folate deficiency * spondyloarthropathies * hepatic disease * advanced renal disease * current lumbosacral radiculopathy or nerve compression * toxin exposure including chemotherapeutic agents

Keywords: neuropathic diabetic foot ulcer nerve decompression surgery
evaluating the utility of the apoptosis imaging biomarker 18f]ml10 in patients with non-hodgkin's lymphoma(nhl)

Conditions: Cancer

Summary: this study aims to evaluate the potential of 2-(5- fluoro pentyl)-2-methyl malonic acid (\[18f\]ml10), as an apoptosis imaging biomarker and its potential to predict response in patients with non hodgkin's lymphoma.

apoptosis or programmed cell death mechanisms are disrupted in cancer cells allowing them to live longer and grow faster than normal cells. apoptosis is a key target for several novel anti-cancer agents. a biomarker that could permit imaging levels of ongoing apoptosis could be a powerful tool in associated drug development programs by providing relevant data to support proof of concept. in addition, use in the clinical setting may permit the tailoring of treatment for individual patients balancing efficacy of treatment with known toxicity levels. this study aims to evaluate the potential of 2-(5- fluoro pentyl)-2-methyl malonic acid (\[18f\]ml10), as an apoptosis imaging biomarker and its potential to predict response in patients with non hodgkin's lymphoma. all patients will have a baseline \[18f\]ml10 pet-ct scan and a post-treatment scan after the initiation of the first course of intravenous chemotherapy. the study aims to enrol unto 16 subjects with non-hodgkins lymphoma.

Eligibility criteria:
inclusion criteria: 1. capable of giving written informed consent, and willing and able to comply with the requirements and restrictions listed in the consent form. 2. male or female patients \>18 years of age at screening with histological or cytological diagnosis of non-hodgkin's lymphoma and due to receive intravenous chemotherapy for the first time 3. a female subject is eligible to participate if she has non-childbearing potential 4. male subject must agree to use one of the contraception methods listed 5. able to lie comfortably on back for up to 70 minutes at a time. 6. who performance status 0, 1 or 2 - exclusion criteria: 1. patients with known history of hepatitis b, c, non-a, non-b and hiv 2. any clinically significant medical conditions that in the opinion of the investigator would compromise the compliance with study procedures. 3. pregnant or breast feeding females. 4. any other prior anticancer therapy 5. any new investigational agent, including an investigational anti-cancer agent 6. history of sensitivity to heparin or heparin-induced thrombocytopenia. 7. males and females not able to comply with contraceptive guidelines during the study. -
discontinuation study of the durability of effect of milnacipran for the treatment of fibromyalgia

Conditions: Fibromyalgia

Summary: the purpose of this study is to evaluate the durability of effect of milnacipran for the treatment of fibromyalgia in patients receiving long-term milnacipran treatment and to characterize the effects of milnacipran on multiple symptoms of fibromyalgia, as demonstrated by changes in symptoms following the discontinuation of milnacipran.


Eligibility criteria:
inclusion criteria: * currently participating in study mln-md-06 * receiving a stable dosage of milnacipran (50-200 mg/d) at screening/enrollment (visit 1) exclusion criteria: * significant risk of suicide * history of mania, bipolar disorder, psychotic disorder, schizophrenia, or a current episode of major depressive disorder * myocardial infarction and/or stroke within the prior 12 months * mean systolic blood pressure \> 180 mm hg or mean diastolic blood pressure \> 110 mm hg at screening (visit 1) * active liver disease * severe renal impairment * platelet and bleeding disorders * female patients who are pregnant or breastfeeding

Keywords: milnacipran pain durability of effect loss of therapeutic response fatigue forest research institute savella ®
are static and dynamic balance tests a criteria showing cognitive impairments in the elderly?

Conditions: Geriatric Population; Balance Problems

Summary: the aim of our study is to reveal whether static and dynamic balance tests can be an indicator of deterioration in cognitive impairments in geriatric individuals.

the static and dynamic balance test will be used to predict cognitive impairments in older adults.

Eligibility criteria:
inclusion criteria: * relative, healthy elderly individuals aged 65-85 years * individuals who do not have neurological / orthopedic problems that will prevent them from performing the test * independent elderly individuals in activities of daily living * men and women living in a nursing home * no pre-defined vision and hearing problems * no history of lower extremity or lumbar spinal surgery exclusion criteria: * hadkinson's abbreviated mental test less than 7 points * presence of defined neurological, orthopedic, systemic (cardiovascular) disease that interferes with walking and mobility * presence of defined psychiatric illness * having a communication problem * presence of using aids for walking * use of prostheses or orthoses associated with the lower extremity * presence of cognitive, visual or auditory impairment * balance-affected individuals with lower extremity disorders

Keywords: geriatria cognitive status balance test
effect of carbohydrate consumption on fatigue and muscle damage in jiu-jitsu athletes

Conditions: Fatigue; Exercise-induced Muscle Damage

Summary: the study is a randomized, double-blinded, placebo-controlled trial that will include the participation of 14 jiu-jitsu athletes between 18 and 33 years. the aim of the study is to evaluate the effects of carbohydrate consumption on fatigue and exercise-induced muscle damage in jiu-jitsu athletes.

brazilian jiu-jitsu (bjj) is a sport characterized by intermittent high-intensity efforts separated by periods of low intensity. muscular strength is considered one of the most important physical components to be developed, especially in the upper limbs through dynamic and static actions. the activities of high intensity (relation effort-pause) carried out by the upper and lower limbs during bjj can induce muscle fatigue. in order to minimize the glycogen depletion and to guarantee the availability of energy substrate to the athlete during the physical exercise, the carbohydrate intake before moderate intensity exercises should be between 5-7 g / kg of weight / day. the intervention group will receive a 30g maltodextrin beverage and the placebo group a non-carbohydrate drink. there will be 3 combat simulations of 8 min each, with intervals of 10 min between fights. athletes will be instructed to remain with their usual intake during the study. the outcomes will be: manual grip strength (dynamometer), upper limb strength (kgst), lower limb strength (vertical jump), subjective exertion perception (borg scale), pain perception (nilsson scale), blood markers of muscle damage (ck and ldh), lactate, and glycemia.

Eligibility criteria:
inclusion criteria: * compete in the categories of weight between 70kg and 88,3kg (weight classification from light to medium heavy, belonging to the bands purple to brown). * age between 18 and 33 years. * be training at least three times a week, minimum of 1,5 hours per day, for at least 3 consecutive months. * have not used anabolic steroids in the last 6 months during the study period. * do not use any type of dietary supplement in the last 3 months. * self-declared healthy individuals. exclusion criteria: * recent muscle injury (within the last 3 months) that compromises and / or impedes the performance of the exercise requested in the study. * be in a time of rapid weight loss (pre-competition).
does percutaneous tibial nerve stimulation (ptns) improve outcomes in patients presenting with fecal incontinence

Conditions: Fecal Incontinence

Summary: the primary objective of this study is to determine whether percutaneous tibial nerve stimulation (ptns), a minimally invasive, simple, cost effective, and outpatient treatment of patients with urinary incontinence, can also be used to treat fecal incontinence. specifically, the primary endpoint of this study is to determine, in a randomized controlled patient blinded study, whether ptns decrease the episodes of fecal incontinence by 50% in the patients treated with ptns when compared to placebo as documented by a 2 week patient bowel diary after treatment. the investigators secondary endpoints will consist of measurements of the impact of ptns on the severity of incontinence (defined as a decrease in the mean fecal incontinence severity index (fisi) score ), as well as on the patient quality of life factors related to fecal incontinence (defined as a decrease in the mean fecal incontinence quality of life (fiqol) scale).


Eligibility criteria:
inclusion criteria: * 18 years or older * able to provide informed consent * has severe fecal incontinence (defined as weekly episodes of incontinence of mucus, liquid or solid stool) * available to present for weekly treatments * available for follow-up at 3, 6, and 12 months exclusion criteria: 1. severe cardiopulmonary disease 2. lesion of the tibial nerve 3. use of a cardiac pacemaker or implantable defibrillator 4. history of inflammatory bowel disease 5. active anal fissure, fistula, or abscess 6. active rectal bleeding which has not been evaluated with appropriate testing, such as colonoscopy 7. has a sphincter injury that needs sphincteroplasty 8. wants to pursue aggressive surgical therapy with a colostomy or an artificial bowel sphincter 9. severe distal venous insufficiency 10. uncontrolled diabetes with peripheral nerve involvement 11. immunosuppression 12. pregnant or planning on becoming pregnant during treatment 13. patients prone to bleeding
a phase 1 study to evaluate escalating doses of a vaccine-based immunotherapy regimen for prostate cancer (prca vbir)

Conditions: Prostatic Neoplasms

Summary: the study will evaluate the safety, pharmacokinetics and pharmacodynamics of increasing doses of a vaccine-based immunotherapy regimen for patients with prostate cancer.


Eligibility criteria:
inclusion criteria: * histological or cytological diagnosis of prostate cancer * adequate bone marrow, kidney and liver function * hormone sensitive relapsing prostate cancer after definitive local therapy (biochemical relapse) or * failed prior therapy with a novel hormone (e.g. enzalutamide, abiraterone) with documented progressive disease (post-novel hormone therapy crpc) exclusion criteria: * ecog performance status greater than or equal to 2 * concurrent immunotherapy for prostate cancer * history of or active autoimmune disorders (including but not limited to: myasthenia gravis, thyroiditis, pneumonitis, rheumatoid arthritis, multiple sclerosis, systemic lupus erythematosus, scleroderma) and other conditions that disorganize or alter the immune system. * history of inflammatory bowel disease. * current use of any implanted electronic stimulation device * for biochemically relapsed patients, no concurrent use of adt or orchiectomy and no known prior or current evidence of any metastatic involvement of distant organs * for post-novel hormone patients, no concurrent treatment with a secondary hormone (e.g. enzalutamide, abiraterone), no metastasis to the liver or brain
posnoc - a trial looking at axillary treatment in early breast cancer

Conditions: Breast Cancer

Summary: posnoc is a pragmatic, randomised, multicentre, non-inferiority trial. aim for women with early stage breast cancer and one or two sentinel node macrometastases, to assess whether adjuvant therapy alone is no worse than adjuvant therapy plus axillary treatment, in terms of axillary recurrence within 5 years. stratification: institution, age (\<50, ≥50), breast-conserving surgery (bcs) or mastectomy, estrogen receptor (er) status (positive, negative), number of positive nodes (1, 2), intra-operative sentinel assessment using osna (yes, no). interventions the study will compare adjuvant therapy alone with adjuvant therapy plus axillary treatment (axillary node clearance (anc) or axillary radiotherapy (art)). sample size: 1900 participants follow-up: participants will be followed up for 5 years. adjuvant therapy: all participants will receive adjuvant systemic therapy (chemotherapy and/or endocrine therapy). all participants may receive breast/chest wall radiotherapy. axillary and supraclavicular fossa radiotherapy is not allowed when randomised to adjuvant therapy alone.


Eligibility criteria:
inclusion criteria: * unifocal or multi-focal invasive tumour with lesion ≤5 cm in its largest dimension, measured pathologically or largest invasive tumour diameter on radiology should be used for women who are randomised intra-operatively or undergo sentinel node biopsy before neoadjuvant therapy (tumour size should be based only on the single largest tumour; do not add the sizes together from the multiple foci) * at sentinel node biopsy have 1 or 2 nodes with macrometastases (tumour deposit \>2.0mm in largest dimension or defined as macrometastasis on molecular assay) * fit for axillary treatment and adjuvant therapy * have given written informed consent exclusion criteria: * bilateral invasive breast cancer * more than 2 nodes with macrometastases * neoadjuvant therapy for breast cancer except: * if sentinel node biopsy performed prior to neoadjuvant chemotherapy in women with early breast cancer * short duration of neoadjuvant endocrine therapy is acceptable (up to 3 months) * previous axillary surgery on the same body side as the scheduled sentinel node biopsy * not receiving adjuvant systemic therapy * previous cancer less than 5 years previously or concomitant malignancy except: * basal or squamous cell carcinoma of the skin * in situ carcinoma of the cervix * in situ melanoma * contra- or ipsilateral in situ breast cancer

Keywords: breast cancer sentinel lymph node biopsy axillary lymph node clearance axillary lymph node dissection macrometastases axillary radiotherapy posnoc
study of acceptability of a new distance-learning tool "myfit"

Conditions: Type1diabetes

Summary: the investigators developed an on-line learning tool "myfit" enabling to patients with t1d to acquire the knowledge and skills for practicing functional insulin therapy from their home. the aim of the present study is to evaluate the acceptability of this new learning modality via the tool "myfit" by the patients and by the health professionnals.


Eligibility criteria:
inclusion criteria: * type one diabetes on intensified insulin therapy exclusion criteria: * hearing loss * visual problems
a trial to reduce referred pain in the shoulder following a laparoscopic gynecological surgery

Conditions: Surgery

Summary: patients undergoing laparoscopic surgery suffer in 30-85% of cases of referred pain in the shoulder in the first days following their intervention. pain can be disabling and may even delay the discharge of patients. several techniques have been proposed to reduce this problem. promising strategies include the reduction of co2 insufflation flow, lung recruitment maneuvers and active aspiration of intraperitoneal air at the end of surgical procedure to force gas discharge. the investigators wish to perform a randomized controlled trial with 160 women, who will assess the effect of a combined approach, combining for the first time lung recruitment maneuvers and aspiration of pneumoperitoneum in the trendelenburg position at the end of surgery and flow of insufflation reduces carbon dioxide (co2) forming the pneumoperitoneum during surgery, on the intensity of shoulder pain postoperatively. in the control group the evacuation of the pneumoperitoneum will be done by opening the trocars and external abdominal pressure at the end of surgery. no study to our knowledge has tested the active aspiration maneuvers gas after laparoscopic surgery in gynecology. the study will be preceded by a pilot study in 15 participants, who will be assigned to the control group to determine the basic rate of referred pain in the shoulder in our people and improve test management.


Eligibility criteria:
inclusion criteria: * women, 18-65 years * physical asa score 1-2 * elective laparoscopic surgery for benign cause * patients who have been informed of the study and has agreed to sign the icf exclusion criteria: * physical asa score 3-4 * pregnant women * chronic pain syndrome or preoperative pain syndrome * narcotics consumption, chronic preoperative analgesia * alcohol or drug dependence * inability to provide telephone follow up at 48 hours * laparoscopy not possible at the umbilical level.

Keywords: gynecological laparoscopic surgery
a randomized controlled trial of mental health peer-led education

Conditions: Mental Disorders

Summary: this randomized controlled trial tests the efficacy of a mental health peer-led educational intervention called bridges (building recovery of individual dreams and goals through education and support). the bridges program is a 10-week, manualized education course designed to provide basic information about the etiology and treatment of mental illness, self-help skills, and recovery principles in order to empower participants to return to valued social roles within their communities. bridges is a peer-led program and all instructors are adults with mental illnesses. for study purposes, the 10-week course was modified to 8-weeks, meeting 2 1/2 hours once a week. hypothesis #1: compared to wait-list controls, intervention participants will report increased feelings of psychological empowerment. hypothesis #2: compared to wait-list controls, intervention participants will report increased feelings of hopefulness. hypothesis #3: compared to wait-list controls, intervention participants will report enhanced coping ability. hypothesis #4: compared to wait-list controls, intervention participants will report enhanced recovery. hypothesis #5: compared to wait-list controls, intervention participants will report greater ability to advocate for themselves with health care providers. hypothesis #6: compared to wait-list controls, those in the bridges education course will report increased knowledge of the causes and treatment of mental illness and recovery principles.

eligibility criteria included having a diagnosis of serious mental illness and experiencing severe functional impairment in one or more life roles. all study participants completed telephone interviews at three points in time: study entry (pre-intervention); 8-weeks later (immediate post-intervention); and 6-months after intervention (approximately 8 months after study entry). blinded interviewers administered valid and reliable outcome assessments that measured changes in subjects' knowledge about mental illness; emotional well-being; empowerment; hopefulness; self-advocacy; and recovery. all study participants were compensated for their time at each interview. all bridges instructors were people in recovery from serious mental illnesses who were certified and experienced bridges teachers. fidelity to the bridges curriculum was assessed on an ongoing basis throughout the study.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of mental illness * disability due to mental illness * age 18 years or older * willingness to receive the intervention exclusion criteria: * inability to understand spoken english

Keywords: serious mental illness psychiatric disability mental health peer-led mental illness education illness self-management